NDAINTRAVENOUSPOWDERPriority Review
Approved
May 2014
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
16
Data completeness
6/8 — Strong
Priority Review
DALVANCE (dalbavancin) by AbbVie is [see microbiology ( )] . First approved in 2014.
Drug data last refreshed 17h ago · AI intelligence enriched 19h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DALVANCE (dalbavancin) is a semi-synthetic lipoglycopeptide antibiotic administered intravenously as a powder for reconstitution. It inhibits bacterial cell wall synthesis and is indicated for acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible Gram-positive organisms. The drug's long half-life enables convenient dosing with extended intervals between administrations.
$0.014BPart D
LOE Approaching1.7 years to LOEModest spending and claim volume with 1.7 years until patent expiry signals a contracting market opportunity requiring cost-containment and retention strategies.
Mechanism of Action
[see Microbiology ( )] .
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (16)
Dalbavancin Real-life Utilization in Diabetic Patients Suffering From Infections (DALBADIA)
Started Jan 2022
98 enrolled
DiabetesInfection
Substance Use Disorder (SUD)-Associated Infections' Treatment With Dalbavancin ENabling OUtpatient Transition
Started Apr 2021
11 enrolled
Gram-Positive Bacterial InfectionsGram-Positive BacteraemiaSubstance Use Disorders+1 more
DOTS: Dalbavancin as an Option for Treatment of Staphylococcus Aureus Bacteremia
Started Apr 2021
200 enrolled
Staphylococcal Bacteraemia
Evaluation of Intravenous Dalbavancin for Peritonitis
Started Jun 2020
2 enrolled
PeritonitisPeritonitis Bacterial
Safety and Efficacy of Dalbavancin Versus Active Comparator in Adult Patients With Osteomyelitis
Started May 2017
1 enrolled
Osteomyelitis
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.